CHMP backs Gazyvaro, Arzerra for first-line CLL

EMA's CHMP backed two drugs for first-line treatment of chronic lymphocytic leukemia (CLL) in patients unsuitable for fludarabine-based therapy. The committee backed approval of Gazyvaro obinutuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) in combination with chlorambucil. Roche already markets obinutuzumab -- a glycoengineered humanized mAb against CD20 -- in the U.S. as Gazyva for the indication.

CHMP also backed a label expansion for Arzerra ofatumumab from Genmab A/S (CSE:GEN; OTCBB:GMXAY) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to include first-line treatment of CLL in combination with chlorambucil or bendamustine. GSK already markets Arzerra in the U.S. for first-line CLL and in the U.S. and EU for CLL refractory to fludarabine and alemtuzumab. The pharma has worldwide co-development and commercialization rights to the human mAb against CD20 from Genmab, which was off DKK0.20 to DKK205.80 on Friday. ...